A strategic alliance that will pool resources and harmonise procedures for clinical trials in North America, Russia and member countries of the Commonwealth of Independent States has been formed by US-based contract research organisation Promedica International and Russian counterpart Synergy Research Group.
The new partners said the alliance reflected the CROs’ “cultural similarities in terms of client orientation and service”. Clients would now have “the opportunity to perform study activities in North America, Russia and CIS member states using common project and data management resources and a single set of standard operating procedures”, commented SynRG founder Elena Zhuk.
Shannon Stoddard, director of clinical services at PMI, will oversee the integration of SOPs and systems to streamline project implementation. SynRG’s specialised knowledge in clinical research “enables us to confidently provide our clients with thoughtful study planning processes, suggestions for proven Russian study sites, and in-country monitoring and site management”, she noted.
Founded in 2002 and based in Moscow, with four other Russian offices in Saint Petersburg, Novosibirsk, Yekaterinburg and Almaty, SynRG offers Phase II-IV clinical research services including project management, study management and monitoring, clinical quality assurance, medical writing and regulatory support.
PMI, a privately held corporation with headquarters in Costa Mesa, California, has been providing Phase II-IV services to the medical device, biotechnology and pharmaceutical industries since 1985. Specialities include clinical study design, management and monitoring, clinical data management and monitoring, medical writing, auditing and training for Good Clinical Practice, and strategic planning for medical product launches.
This is the second strategic alliance the US CRO has established in the last few months. In April PMI announced a similar arrangement with Iris Pharma, a French CRO specialising in ophthalmology research.
Russia was among the first wave of countries to benefit from the exodus of clinical trials from established markets to emerging territories with cost and other advantages such as large patient populations and relative ease of recruitment. A recent analysis by CRO Parexel showed that Russia attracted only slightly fewer trials regulated by the US Food and Drug Administration than the UK in 2006.